Associate Director, Clinical Operations
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Title: Associate Director Clinical Operations
Location: San Diego
Job Type: Full-Time
Who We Are
Avenzo Therapeutics Inc. (Avenzo or Company) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics Inc. respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego California.
Position Summary
Reporting to the Executive Director Clinical Operations the Associate Director Clinical Operations will be responsible for the operational aspects of clinical studies. As the operational lead for individual studies this individual will serve as the primary point of contact for contract service providers (CSPs) involved in all study aspects and will independently work cross-functionally for the successful execution of clinical trials from the protocol concept through the clinical study report ensuring completion of study deliverables
Essential Job Functions and Responsibilities
- Lead and oversee the planning implementation and execution of one or more clinical trials across one or more key programs in accordance with project timelines and budget
- Oversee contract research organization (CRO) and vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management including but not limited to site selection study start-up recruitment study conduct and database lock and study close-out
- Develop and manage comprehensive program project plans including but not limited to study protocols clinical trial budgets timelines enrollment and risk mitigation strategies
- Ensure clinical trials are conducted according to Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements SOPs and other quality standards
- Develop relationships with investigators and trial site administrators
- Support development of infrastructure with an emphasis on implementation and use of harmonized consistent processes and excellence in study management deliverables related to cost-effective timely and high-quality clinical trial data
- Support the creation of internal SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & Global regulations; evaluates and recommends changes to policies or procedures
- Present at Investigator Meetings as needed
- Effectively communicate clinical trial updates to the team and other appropriate functional groups
- Collaborate with cross-functional teams to support scenario-based planning to forecast resource and budget needs to contribute to the clinical development plan and execution
- Review resource allocation utilization and cost efficiency across all clinical trials
- Serve as the subject matter expert (SME) on study protocol and operations and ensure proper training and education of internal and external resources
- Contribute to the preparation and review of clinical study documents including the Investigator Brochure Investigational New Drug Applications (IND) study protocols clinical study reports applicable sections of New Drug Applications (NDA) and/or Marketing Authorization Application (MAA) updates to the IND NDA and other safety reports
Preferred Qualifications
- Bachelors degree required advanced medical or life sciences or a related area degree preferred (e.g. MS PhD) with 10 years of experience in the life sciences industry or an equivalent combination of academic and industry experience
- Working knowledge of the processes required to operationally execute clinical trials
- Demonstrated capability to proactively manage vendor-supplied resources
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required particularly ICH and GCP
- Demonstrated track record in conducting clinical trials in an outsourced model
- Significant experience working in a fast-paced biotech environment
- Experience participating in GCP inspection readiness as part of NDA/MAA activities
- Strong understanding of FDA regulations GCP ICH guidelines and clinical research SOPs
- Excellent communication and interpersonal skills with the ability to collaborate effectively with internal and external stakeholders
- Strong analytical and problem-solving abilities with a strategic mindset
- This position requires periodic/regular travel including up to 15% of work time which may include overnight travel
Physical Demands and Work Environment
Physical Demands:
- Constant or continuous use of a computer keyboard monitor and mouse to perform a variety of tasks
- Constant or frequent sitting standing or walking
- May lift and/or move objects of various weights
Work Environment:
- On-site requirement (Monday through Thursday)
- Noise level in the work environment is usually moderate
- Fast-paced time sensitive environment with frequently changing priorities
- Handle multiple projects simultaneously
Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.
Salary Range
The salary range for this position is $173000 to $194000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job and the industry education and skills and certifications.
Benefits
Provided they meet all eligibility requirements under the applicable plan documents employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical dental vision and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance flexible spending accounts health savings accounts and voluntary insurance programs including voluntary life AD&D accident and critical illness. Employees will also be able to enroll in the Companys 401(k) addition employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year including a winter closure subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies which may be amended from time to time.
Other Compensation
The hired candidate will be eligible to receive an annual discretionary bonus and an equity award subject to the terms of the applicable employment agreement plan documents and Company policies.
The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.
Applications for this position are anticipated to close on August 31 2026. For more information about this posting please contact .
Equal Employment Opportunity
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individuals actual or perceived protected characteristic or characteristics or any combination of protected characteristics including race (including traits associated with race such as hair texture and protective hairstyles including braids locks and twists) ethnicity religion religious creed (including religious dress and grooming practices) color sex (including childbirth breast feeding and related medical conditions) gender gender identity or expression sexual orientation national origin ancestry citizenship status uniformed service member and veteran status marital status pregnancy age (40 and over) protected medical condition (including cancer and genetic conditions) genetic information disability (mental and physical) reproductive health decision-making medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act) the employee or their family members status as a victim of a qualifying act of violence political activity or affiliation use of cannabis off the job and away from the workplace association with an individual who has or is perceived to have a protected characteristic or characteristics or any combination of protected characteristics or any other protected status in accordance with all applicable federal state and local laws.
Notice to Search Firms/Third Party Agencies
Avenzo does not accept unsolicited resumes from recruiters employment agencies or search firms without a valid executed search agreement in place.
Required Experience:
Director
